FDA · official record K240328Substantially Equivalent

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Name: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) — FDA K240328
Creator: Signifier Medical Technologies, Ltd.
Keywords: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000), eXciteOSA without remote control (3000); eXciteOSA with remote control (6000), K240328, QNO, FDA

United StatesQNOSignifier Medical Technologies, Ltd.

Verified

Official record identity

FDA application number: K240328
Decision date: May 16, 2024
Published decision: Substantially Equivalent

Classification

Product code: QNO

Published parties

Applicant: Signifier Medical Technologies, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2024-02-05
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5575

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.